What is Ovaleap - follitropin alfa used for?
Ovaleap is a medicine that contains the active substance follitropin alfa . It is used for the treatment of the following groups:
- women who cannot ovulate and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
- women undergoing assisted reproduction techniques such as in vitro fertilization. Ovaleap is given to stimulate the ovaries to produce more than one egg at a time;
- women with severe impairment (very low levels) of luteinizing hormone (LH) and follicle stimulating hormone (FSH). Ovaleap is given along with a medicine containing LH to stimulate the eggs to mature in the ovaries;
- men with hypogonadotrophic hypoganodism (a rare disease characterized by hormonal deficit). Ovaleap is used together with human chorionic gonadotropin (hCG) to stimulate sperm production. Ovaleap is a "biosimilar" medicine. This means that Ovaleap is similar to a biological medicine (the so-called "reference medicine") that has already been authorized in the European Union (EU) and that Ovaleap and the reference medicine both contain the same active substance. The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the questions and answers section by clicking here.
How is Ovaleap - follitropin alfa used?
Ovaleap is available as a solution for injection. The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating fertility disorders. Ovaleap is given by subcutaneous injection once a day. The dosage and frequency of administration of Ovaleap depend on the use for which it is intended and the patient's response to treatment. After the first injection, the patient or his partner can give the injections independently, as long as they are properly motivated, educated and with the possibility of having recourse to an expert's advice. For more information, see the package leaflet.
How does Ovaleap - follitropin alfa work?
The active substance in Ovaleap, follitropin alfa, is a copy of the natural FSH hormone. In the body, FSH regulates reproductive function: in women it stimulates the production of eggs, while in men it stimulates the production of sperm by the testicles. In the past, FSH used in medicines was extracted from urine. The follitropin alfa contained in the medicinal product Ovaleap and in the reference medicinal product is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce human FSH .
What benefit has Ovaleap - follitropin alfa shown during the studies?
Ovaleap was compared with GONAL-f in a main study involving 299 women undergoing assisted reproduction techniques. The main measure of effectiveness was the number of collected oocytes (mature eggs). Ovaleap has been shown to be just as effective as the reference medicine, GONAL-f. On average 12.2 oocytes were collected in the group treated with Ovaleap compared to 12.0 oocytes collected in the group treated with GONAL-f.
What is the risk associated with Ovaleap - follitropin alfa?
The most common side effects associated with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, erythema, hematoma, swelling or irritation). In women, ovarian cysts (fluid sacs in the ovaries) and headaches are also seen in more than 1 in 10 patients. For the full list of side effects reported with Ovaleap, see the package leaflet. Ovaleap should not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH or any of the other ingredients. It must not be used in patients with cancer of the pituitary gland or hypothalamus, lungs, uterus or ovaries. It should not be used in patients where an effective response is not possible, such as those with ovarian or testicular insufficiency or women whose pregnancy is not recommended for medical reasons. In women Ovaleap should not be used in the presence of an enlarged ovary or an ovarian cyst not due to polycystic ovarian disease, or unexplained vaginal bleeding. For the full list of limitations, see the package leaflet. In some women the ovaries may over-respond to stimulation. This phenomenon is called "ovarian hyperstimulation syndrome". Physicians and patients should be aware of this possibility.
Why has Ovaleap - follitropin alfa been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a similar profile to GONAL-f with regard to quality, safety and efficacy. Therefore, the CHMP's opinion is that, as with GONAL-f, the benefits of Ovaleap outweigh its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Ovaleap - follitropin alfa?
A risk management plan has been developed to ensure that Ovaleap is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the information sheet on Ovaleap, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Ovaleap - follitropin alfa
On 27 September 2013, the European Commission issued a marketing authorization for Ovaleap, valid throughout the European Union. For the full EPAR of Ovaleap consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Ovaleap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2013.
